Catalog Number 3095040 |
Device Problems
Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that when opened, the outer bag also ripped open the inner bag, so content was not sterile anymore to give to the scrubbed nurse; like if the bags were stock together.Was surgery delayed due to the reported event? no.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code - 3095040, lot number - 4200494, and no non-conformances / manufacturing irregularities were identified.Manufacturing date: 2023-06-21 expiry date: 2025-05-31 quantity: (b)(4).There were zero nonconformances on this lot.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device product code - 3095040, lot number - 4200494, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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